S02 Combined Synopsis-Solicitation-36C24726Q0075-BC Reviewed.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Watch Pat One Direct Services and Devices Brand Name or Equal to

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

SOLICITATION NUMBER*

RESPONSE DATE/TIME/ZONE

ARCHIVE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

NAICS CODE*

CONTRACTING OFFICE ADDRESS

POINT OF CONTACT*

36109-3798

36C24726Q0075

11-07-2025 10AM EASTERN TIME, NEW YORK,

USA

15 DAYS AFTER THE RESPONSE DATE

N

SDVOSBC

Q201

339112

Department of Veterans Affairs

Central Alabama Veterans Health Care

West Campus

215 Perry Hill Road

Montgomery AL 36109-3798

CONTRACT SPECIALIST

Monica Reed

Monica.Reed@va.gov

Email Only

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs

Ralph H. Johnson VA Medical Center

109 Bee Street

Charleston SC

POSTAL CODE 29401

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS va.gov

EMAIL DESCRIPTION Department of Veterans Affairs

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation 36C24726Q0075 is issued as a request for quote (RFQ). No telephone requests will be accepted. Only written requests received directly from the offeror are acceptable. The associated North American Industry Classification System (NAICS) code for this procurement is 339112

- Surgical and Medical Instrument Manufacturing, with a small business size standard of 1000

Employees.

This solicitation is 100% set-aside for SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESSES (SDVOSBs).

Domestically produced (made in the USA) products are requested, pursuant to the Buy American

Act.

Preferred Brand Name: WATCHPAT ONE DIRECT SERVICES AND DEVICES

*Salient characteristics for equivalent brand(s) on pages 6-7, and Page 31-Section D

1.0 Introduction- WatchPat Direct Service

1.1 The Respiratory Department at the Ralph H. Johnson VA Medical Center, located at 109

Bee Street, Charleston, South Carolina 29401-5703, requires the WatchPAT device to assist with the challenges of caring for patients due to COVID-19 pandemic. The

WatchPAT device is a non-invasive home care device for use with patients suspected of having sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor.

1.2 WatchPAT Direct provides this service in the following manner:

1.2.1 Healthcare provider schedules date of study in Cloud PAT with the necessary shipping information.

1.2.2 A WatchPAT kit is prepared per provider's instructions.

1.2.3 WatchPAT kit is shipped to the patient per provider's instructions.

1.2.4 Patient receives a call on scheduled test day from WatchPAT Direct Team to review instructions. The patient can also call the Patient Support Center 24/7 for help.

1.2.5 Patient completes the test in the comfort of their own bed.

1.2.6 The next day, the patient ships the device back to ltamar using prepaid shipping label.

1.2.7 Once the device is returned, the study is uploaded to CloudPAT and sent to referring physician*

2.0 P e r i o d of Performance.

We will be pursuing a base year with four option years 11/17/2025-11/16/2026 Option Year one (1) 11/17/2025-11/16/2026 Option Year two (2) 11/17/2026-11/16/2027 Option Year three (3) 11/17/2027-11/16/2028 Option Year four (4) 11/17/2028-11/16/2029

3.0 Deliverables: All materials are installed, calibration completed, documentation represented, user in- serviced; warranty installed, and tech support details are in place to provide necessary assistance as required through the company.

3.1 Conformance to all applicable VHA biomedical device requirements

3.2 This device will not require purchase of new materials or supplies in order to conduct diagnostic studies.

ITMCS21170XX 1 ITM CS 2117002 WATCHPAT ONE DIRECT PROGRAM.

To include device and services ordered as: ITM CS21170XX

Device Parts

• Embedded actigraph

• Embedded pulse oximeter

• Embedded CPU and electrical circuit card

• Embedded micro SD card drive

• Rechargeable Lithium Ion Battery

• uPAT probe (includes oximetry)

• uPAT probe connection cable

• Wrist Strap

• AC adapter/ USB cable

• Carrying case

• Step-by-Step Reference Guide

• Quick Reference Cards

4.0 Salient Characteristics/Capabilities

Must be FDA-Approved

Must Improve Workflow

Must be compatible with VA System CPRS

• Immediate access to sleep data and study results.

• Data interpretation anytime, anywhere with cloud-based solution.

• Requires less back-office support.

Must Be Disposable

• No return shipment.

• Must not require cleaning, downloading, or charging.

• No infection risk.

Sleep Architecture

• MUST calculate AHI and RDI using the patient’s Total Sleep Time rather than the recorded time.

• MUST validate sleep staging, which detects wake, light sleep, deep sleep, and REM, provides information on sleep architecture. It also provides the added value of detecting REM related sleep apnea with REM and non-REM AHI.

• MUST feature a Central+ sensor module that enables specific identification of Central Sleep Apnea (CSA) and Percent of Sleep Time with Cheyne-Stokes Respiration.

Comprehensive Automated Reporting

• MUST be able generate report in seconds

• MUST be capable of generating reporting on all of the following:

▪ Apnea/Hypopnea per hour

▪ Sleep Stages (unique to WatchPAT)

▪ Central AHI Apnea/Hypopnea per hour

▪ Body Position Statistics and Graphic Display

▪ Apnea Episodes through the night

▪ Snoring Statistics

▪ Sleep Stages by Graphic Display

▪ Snoring and Body Position

▪ Respiratory Indices Chart

▪ Oxygen & Heart Rate (note precipitous drops)

▪ AHI Severity Scale

This Request for Quote (RFQ) is issued in accordance with FAR 12 and in conjunction with

Simplified Acquisition Procedures FAR 13.5. Evaluation of price and other factors will be performed in accordance with procedures outlined in FAR 13.106-3. A single award will be made utilizing comparative analysis, considering technical approach, past performance, meeting of salient characteristics equivalent to the Watchpat Direct One , and price.

(a) The Government will award a contract resulting from this solicitation to the proposer whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical: The technical evaluator will evaluate the offerors’ quote to fulfill this requirement.

The offeror will show its understanding of the requirement and the viability of its quote by demonstrating its plan of action to provide this service, demonstration of knowledge of the service and ability to perform by providing a detailed plan of equipment required to fulfill the need and to perform the procedures you will use while executing the requirement.

-All Offers must provide statement that proposed devices are FDA-Approved.

-Offers will be evaluated on their proposed device’s ability to meet all Salient

Characteristics/Capabilities of the Brand Name, WatchPAT One Direct device and services as prescribed in the provision below.

VHAV07FieldC Comment on Text Change to meeting the characteristics equivalent to WATCHPAT ONE DIRECT to include the salient characteristics.

Per FAR Part 52.211-6 Brand Name or Equal,

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including

"equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

Past Performance: The offeror is required to provide a minimum of two (2) past performance references for similar services within the last two (2) years, either Governmental or Commercial entity, in response to this solicitation, to include place, size, and years of service performed. If no past performance is available, you must address this in your offer. Past performance will be reviewed as part of the responsibility determination only.

Price: The contracting officer will evaluate the offered price to determine whether it is fair and reasonable in accordance with FAR 13.106-3. The total evaluated price is the offeror’s price to include all options.

Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume

VHAV07FieldC

Recommend including a statement that shows a overall similar experience of 10 years with 2 years of recent experience.

that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR

52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all proposals relative to each other, and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the

Government to exercise any option under FAR 52.217-8.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the

Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

All questions should be emailed to Monica.Reed@va.gov November 03, 2025 at 12:00 PM

ET No late submissions will be ACCEPTED. All responses to questions shall be incorporated into a written amendment posted to the Government Point of Entry (GPE). The offeror is encouraged to monitor the GPE, Beta.SAM website with respect to this solicitation because any amendments to this Solicitation will be posted on the website (www.beta.sam.gov).

There will be no automated email notification of amendments.

Quotes must be received by November 07, 2025, by 10:00 AM ET. Email your quote to

Monica.Reed@va.gov. The subject line must have the solicitation the offeror is responding to listed. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. Not providing all the required documents above along with not following the instructions for submission will result in an unacceptable quote.

VHAV07FieldC Comment on Text Far to short turn around at least 5 days

VHAV07FieldC too short. Need to be more like Nov 13

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

534-26-1-2291-0002

36C24726Q0075 10-28-2025

Monica Reed Email Only 11-04-2025

12:00pm EST

36C247

Department of Veterans Affairs

Central Alabama Veterans Health Care

West Campus

215 Perry Hill Road

Montgomery AL 36109-3798

X 100

X

339112

1000 Employees

NET 30

N/A

X

Charleston VA Healthcare System

Ralph H. Johnson VA Medical Center

109 Bee Street

Charleston SC 29401

36C247

Department of Veterans Affairs

Central Alabama Health Care System

West Campus

215 Perry Hill Road

Montgomery AL 36083-5001

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Contractor shall provide WATCHPAT Direct services and devices to the Ralph H. Johnson VA Medical as outlined in the Price Schedule, Statement of Work, and Salient

Characteristics below.

Please contact Monica Reed for all Requests for information at Monica.Reed@va.gov by 11/03/2025 NLT 12:00 PM ET No late Responses will be accepted.

All responses due by 11/07/2025 NLT 10:00 AM

See CONTINUATION Page

534-3660160-2291-821200-2560 010021251

X X

X 1

Earnest Ellison

Contracting Officer NCO 07

36C24726Q0075

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

STATEMENT OF WORK

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 30

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 36

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

DEVICE SALIENT CHARACTERISTICS/CAPABILITIES

SECTION E - SOLICITATION PROVISIONS

E.1 52.211- BRAND NAME OR EQUAL

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.6 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.7 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.8 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.9 52.214-21 DESCRIPTIVE LITERATURE (APR 2002)

E.10 52.216-1 TYPE OF CONTRACT (APR 1984)

E.11 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.12 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.13 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.14 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

E.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247-Earnest Ellison

Department of Veterans Affairs

Central Alabama Veterans Health Care

West Campus

215 Perry Hill Road

Montgomery AL 36109-3798

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] Upon Invoicing; Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

-The final payment shall be made within thirty (30) days following the date of final delivery of the goods/services or the end of the performance period, whichever occurs later. Failure to submit a proper invoice and necessary documentation within this period shall delay the final payment accordingly. If the final payment is not made within thirty (30) days of the final delivery or end of the performance period, the contract shall be considered closed, and the contractor shall have no further claims against the government under this contract, except for any claims that are specifically reserved or permitted by the terms of this agreement.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Department of Veterans Affairs, FMS-VA-2(101), Financial Services Center, PO Box 149971, Austin TX 78714-9971

VHAV07FieldC Comment on Text Add a #5. Final Payment. Final Payment Terms

The final payment shall be made within thirty (30) days following the date of final delivery of the goods/services or the end of the performance period, whichever occurs later. Failure to submit a proper invoice and necessary documentation within this period shall delay the final payment accordingly.

If the final payment is not made within thirty (30) days of the final delivery or end of the performance period, the contract shall be considered closed, and the contractor shall have no further claims against the government under this contract, except for any claims that are specifically reserved or permitted by the terms of this agreement. After this period, the government shall be released from any further obligations or liabilities related to this contract.

AMENDMENT NO DATE

STATEMENT OF WORK

1.0 Introduction- WatchPat Direct Service

1.1 The Respiratory Department at the Ralph H. Johnson VA Medical Center, located at 109 Bee

Street, Charleston, South Carolina 29401-5703, requires the WatchPAT device to assist with the challenges of caring for patients due to COVID-19 pandemic. The WatchPAT device is a non-invasive home care device for use with patients suspected of having sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep

Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index

("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification

(PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor.

1.2 WatchPAT Direct provides this service in the following manner:

1.2.1 Healthcare provider schedules date of study in Cloud PAT with the necessary shipping information.

1.2.2 A WatchPAT kit is prepared per provider's instructions.

1.2.3 WatchPAT kit is shipped to the patient per provider's instructions.

1.2.4 Patient receives a call on scheduled test day from WatchPAT Direct Team to review instructions. The patient can also call the Patient Support Center 24/7 for help.

1.2.5 Patient completes the test in the comfort of their own bed.

1.2.6 The next day, the patient ships the device back to ltamar using prepaid shipping label.

1.2.7 Once the device is returned, the study is uploaded to CloudPAT and sent to referring physician*

2.0 Period of Performance.

We will be pursuing a base year with 2000 Units and four option years

Option Year one (1) with 2200 Units

Option Year two (2) with 2400 Units

Option Year three (3) with 2600 Units

Option Year four (4) with 2800 Units

3.0 Deliverables: All materials are installed, calibration completed, documentation represented, user in-serviced; warranty installed, and tech support details are in place to provide necessary assistance as required through the company.

3.1 Conformance to all applicable VHA biomedical device requirements

3.2 This device will not require purchase of new materials or supplies in order to conduct diagnostic studies.

ITMCS21170XX 1 ITM CS 2117002 WATCHPAT ONE DIRECT PROGRAM.

To include device and services ordered as: ITM CS21170XX

Device Parts

• Embedded actigraph

• Embedded pulse oximeter

• Embedded CPU and electrical circuit card

• Embedded micro SD card drive

• Rechargeable Lithium Ion Battery

• uPAT probe (includes oximetry)

• uPAT probe connection cable

• Wrist Strap

• AC adapter/ USB cable

• Carrying case

• Step-by-Step Reference Guide

• Quick Reference Cards

4.0 Device Salient Characteristics/Capabilities

Must be FDA-Approved

Must Improve Workflow

• Immediate access to sleep data and study results.

• Data interpretation anytime, anywhere with cloud-based solution.

• Requires less back-office support.

Must Be Disposable

• No return shipment.

• Must not require cleaning, downloading, or charging.

• No infection risk.

Sleep Architecture

• MUST calculate AHI and RDI using the patient’s Total Sleep Time rather than the recorded time.

• MUST validate sleep staging, which detects wake, light sleep, deep sleep, and REM, provides information on sleep architecture. It also provides the added value of detecting REM related sleep apnea with REM and non-REM AHI.

Must be compatible with CPRS

• MUST feature a Central+ sensor module that enables specific identification of Central Sleep

Apnea (CSA) and Percent of Sleep Time with Cheyne-Stokes Respiration.

Comprehensive Automated Reporting

• MUST be able generate report in seconds

• MUST be capable of generating reporting on all of the following:

▪ Apnea/Hypopnea per hour

▪ Sleep Stages (unique to WatchPAT)

▪ Central AHI Apnea/Hypopnea per hour

▪ Body Position Statistics and Graphic Display

▪ Apnea Episodes through the night

▪ Snoring Statistics

▪ Sleep Stages by Graphic Display

▪ Snoring and Body Position

▪ Respiratory Indices Chart

▪ Oxygen & Heart Rate (note precipitous drops)

▪ AHI Severity Scale

5.0 Applicable Directives: VA Directive 6500 Appendix A; VA Directive 6550; Appendix C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with

VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order

12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of

Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S.

to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

2. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data-

General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure

VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and

Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and

Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA

Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if

NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business

Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or

Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

6. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident

(including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals.

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification.

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least

3 relevant credit bureau reports.

(3) Data breach analysis.

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution.

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

9. TRAINING

a. All contractor employees and subcontractor employees require access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for

VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special

Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

3.0 Records Management Obligations

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle

Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

• includes [Agency] records.

• does not include personal materials.

• applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

• may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII

Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy

Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44

U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. RHJ VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAMC. The agency must report promptly to

NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAMC control or the

Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The

Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with RHJ VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public RHJ VAMC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The RHJ VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11.Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take RHJVAMC-provided records management training. The

Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

3. Violation by a subcontractor of any provision set forth in this clause will be attributed to the

Contractor.

End of SOW

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2,000.00 EA __________________ __________________

ITMCS21170XX 1 ITM CS 2117002 WATHPT ONE DIRECT

PROGRAM. PROGRAM INCLUDES DEVICE AND SERVICES

ORDERED AS: ITM CS21170XX

Contract Period: Base POP Begin: 11-17-2025 POP End: 11-16-2026

LOCAL STOCK NUMBER: ITM CS2117002

2,200.00 EA __________________ __________________

PROGRAM. PROGRAM INCLUDES DEVICE AND SERVICES

ORDERED AS: ITM CS21170XX

Contract Period: Option 1 POP Begin: 11-17-2026 POP End: 11-16-2027

2,400.00 EA __________________ __________________

PROGRAM. PROGRAM INCLUDES DEVICE AND SERVICES

ORDERED AS: ITM CS21170XX

Contract Period: Option 2 POP Begin: 11-17-2027 POP End: 11-16-2028

2,600.00 EA __________________ __________________

PROGRAM. PROGRAM INCLUDES DEVICE AND SERVICES

ORDERED AS: ITM CS21170XX

Contract Period: Option 3 POP Begin: 11-17-2028 POP End: 11-16-2029

2,800.00 EA __________________ __________________

PROGRAM. PROGRAM INCLUDES DEVICE AND SERVICES

ORDERED AS: ITM CS21170XX

Contract Period: Option 4 POP Begin:…